The invention relates to a prosthetic occlusive device for occluding an internal passageway of the human body, for example, for closing the urinary canal in controlling the bladder function where a person has lost bladder control. Implantable devices have been used before for controlling bladder functions and for occluding other internal passageways in the human body such as shown in U.S. Pat. Nos. 2,455,289; 3,750,194; and 3,863,622; which utilize an inflatable or pressurized cuff which is pressurized by means of a fluid actuator. U.S. Pat. No. 4,019,499 discloses an implant device for urinary incontinence in which the fluid volume and pressure may be adjusted after implant. However, devices of these types do not effectively accommodate tubular organs of varying diameters nor effectively permit readjustment of operating pressures due to changing conditions after implant.
In the cuff type devices, fluid cannot be readily added intra-operatively due to the inherent characteristics of the designs of the prior art devices and fluid cannot be added postoperatively without re-operation. Accordingly, no adjustment can be made to the device for growth, atrophy or scarring by means of adding or removing fluid after implantation.
Furthermore, it has been found that the prior art devices have not been entirely satisfactory in control of the pressures required to effectively occlude the organ. The pressurization actually transmitted to cuff and organ may exceed or be less than that required to occlude the organ due to changed conditions. Excess pressures to the organ often results in tissue damage to the organ.
Accordingly, an important object of the present invention is to provide an occlusive device for occluding a tubular organ in which operating pressure adjustments may be made in an implanted device to compensate for changing patient conditions such as growth, atrophy, and scarring without separating.
Yet another important object of the present invention is to provide an occlusive device for occluding tubular organs which will readily accommodate organs of different diameters.
Still another important object of the present invention is to provide an occlusive cuff device for occluding an organ in which fluid may be added to or removed from the device after implantation for adjusting operating pressures.
Yet another important object of the present invention is to provide an occlusive device for surgical implantation for occluding a tubular organ wherein the fluid volume required to effect closure may be sent within a limited range by utilizing a two-chamber inflatable cuff wherein one chamber is attached to a pressurizing valve, and the other chamber is attached to a subcutaneously implanted septum in which fluid can be added subcutaneously by means of a hypodermic needle.